BACKGROUND: Induction of immunosuppression with antibodies after heart transplantation decreases early acute rejection rate compared with placebo. We tested the non-inferiority of basiliximab vs rabbit anti-thymocyte globulin (RATG) on the incidence of acute rejection 6 months after transplantation. METHODS:From July 2002 to April 2004, 35 patients were enrolled in a multicenter, parallel group, open-label, non-inferiority trial. Patients were randomized to receive induction treatment with basiliximab (20 mg on Day 0 and 4) or RATG (125 mg on Day 0, 1, and 2). Standard maintenance therapy with cyclosporine, mycophenolate mofetil, and prednisone was used. RESULTS:Seventeen patients (aged 54 +/- 9 years old) received basiliximab, and 18 patients (aged 54 +/- 12 years old) received RATG. The freedom rate of rejection at 6 months (grade 3A or more) averaged 65% (11/17) with basiliximab and 83% (15/18) with RATG. The upper limit of the 1-sided 90% confidence interval for the difference RATG-basiliximab was 37.2%, exceeding the 22.5% non-inferiority margin. CD3 and CD4 levels were higher (p < 0.0001 for both), whereas CD25/CD4 and CD25/CD8 levels were lower (p < 0.0001 and p = 0.0462, respectively) in patients treated with basiliximab. One of the 14 basiliximab patients showed detectable cytomegalovirus viral load during the first 3 months after transplantation, whereas cytomegalovirus was detected by quantitative polymerase chain reaction in the plasma of 5 of the 13 RATG patients (p = 0.0505). CONCLUSION: Non-inferiority of basiliximab treatment for prophylaxis of acute rejection after heart transplantation could not be shown. RATG administration is associated with a higher rate of asymptomatic cytomegalovirus viral load detection in the plasma.
RCT Entities:
BACKGROUND: Induction of immunosuppression with antibodies after heart transplantation decreases early acute rejection rate compared with placebo. We tested the non-inferiority of basiliximab vs rabbit anti-thymocyte globulin (RATG) on the incidence of acute rejection 6 months after transplantation. METHODS: From July 2002 to April 2004, 35 patients were enrolled in a multicenter, parallel group, open-label, non-inferiority trial. Patients were randomized to receive induction treatment with basiliximab (20 mg on Day 0 and 4) or RATG (125 mg on Day 0, 1, and 2). Standard maintenance therapy with cyclosporine, mycophenolate mofetil, and prednisone was used. RESULTS: Seventeen patients (aged 54 +/- 9 years old) received basiliximab, and 18 patients (aged 54 +/- 12 years old) received RATG. The freedom rate of rejection at 6 months (grade 3A or more) averaged 65% (11/17) with basiliximab and 83% (15/18) with RATG. The upper limit of the 1-sided 90% confidence interval for the difference RATG-basiliximab was 37.2%, exceeding the 22.5% non-inferiority margin. CD3 and CD4 levels were higher (p < 0.0001 for both), whereas CD25/CD4 and CD25/CD8 levels were lower (p < 0.0001 and p = 0.0462, respectively) in patients treated with basiliximab. One of the 14 basiliximabpatients showed detectable cytomegalovirus viral load during the first 3 months after transplantation, whereas cytomegalovirus was detected by quantitative polymerase chain reaction in the plasma of 5 of the 13 RATG patients (p = 0.0505). CONCLUSION: Non-inferiority of basiliximab treatment for prophylaxis of acute rejection after heart transplantation could not be shown. RATG administration is associated with a higher rate of asymptomatic cytomegalovirus viral load detection in the plasma.
Authors: H Haddad; D Isaac; J F Legare; P Pflugfelder; P Hendry; M Chan; B Cantin; N Giannetti; S Zieroth; M White; W Warnica; K Doucette; V Rao; A Dipchand; M Cantarovich; W Kostuk; R Cecere; E Charbonneau; H Ross; N Poirier Journal: Can J Cardiol Date: 2009-04 Impact factor: 5.223
Authors: Andreas Zuckermann; Uwe Schulz; Tobias Deuse; Arjang Ruhpawar; Jan D Schmitto; Andres Beiras-Fernandez; Stephan Hirt; Martin Schweiger; Laurenz Kopp-Fernandes; Markus J Barten Journal: Transpl Int Date: 2014-11-11 Impact factor: 3.782
Authors: Tambi Jarmi; Nirav Patel; Sadaf Aslam; George Makdisi; Elias Doumit; Rahul Mhaskar; Branko Miladinovic; Mark Weston Journal: Ann Transplant Date: 2018-06-19 Impact factor: 1.530